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APPENDICES
The following appendices contain specifications related to various components referenced
throughout this document. These appendices provide the necessary details to facilitate the
preparation of a valid ICH ICSR message or an ICSR Acknowledgment message for electronic
submission.
APPENDIX I – PREPARING AND SENDING ICH ICSRS:
Appendix I (A) – ICH ICSR SCHEMAs
1. List of schemas for ICH ICSR messages and ICSR Acknowledgement messages
The necessary schemas for creating or exchanging ICH ICSR messages and ICH
Acknowledgement messages are listed as schema file names which can be identified from
Appendix I (C) schema files. These schemas are included in a published standard package
named ISO/HL7 27953-2 (published on 21 November 2011). HL7 has developed each schema
as an individual file, and used XML ‘include’ statements to link these files. All schema files
with user guidance are listed by categorisation.
Major Category Sub-Category Schema File Name
a. Core Schemas:
A common schemas
underlying HL7
messages
-infrastructureRoot
datatypes-base
datatypes
voc
b. Send Batch
Interaction:
A schema set specific to
ICSR messages
ICSR Batch Interaction:
Batch wrapper schemas for single or
multiple ICSR messages
MCCI_IN200100UV01
MCCI_MT200100UV
ICSR Single Interaction:
Schemas for individual ICSR
message
PORR_IN049016UV
MCCI_MT000100UV01
MCAI_MT700201UV01
PORR_MT049016UV
PORR_MT049023UV
ICSR Common Product Model
CMET:
Schemas for medicinal products
POCP_MT010200UV
POCP_MT020200
POCP_MT030100UV
POCP_MT030200UV
POCP_MT040100UV
POCP_MT050100UV
POCP_MT081100UV
c. Send Response Batch
Interaction:
A schema set for
Acknowledgement
messages
Acknowledgement Batch
Interaction:
Batch wrapper schemas for
Acknowledgement messages
MCCI_IN200101UV01
MCCI_MT200101UV
Acknowledgement Single
Interaction:
MCCI_IN000002UV01
MCCI_MT000200UV01